Ideaya Biosciences Announced The FDA Clearance Of An Investigational New Drug Application To Initiate GSK-sponsored Phase 1/2 Trial To Evaluate GSK101 (IDE705) In Combination With Niraparib For Tumors With BRCA Or Other Homologous Recombination Mutations
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Ideaya Biosciences has announced FDA clearance of an Investigational New Drug application to initiate a GSK-sponsored Phase 1/2 trial for GSK101 (IDE705) in combination with Niraparib for tumors with BRCA or other homologous recombination mutations. IDEAYA will receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitors.
August 21, 2023 | 10:03 am
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POSITIVE IMPACT
IDEAYA Biosciences will receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitors.
The FDA clearance of the IND application is a significant regulatory milestone for IDEAYA Biosciences. The $7 million milestone payment will provide immediate financial benefit, and the potential for up to $950 million in future milestones presents a substantial revenue opportunity.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEUTRAL IMPACT
GlaxoSmithKline is sponsoring the Phase 1/2 trial for GSK101 (IDE705) in combination with Niraparib for tumors with BRCA or other homologous recombination mutations.
As the sponsor of the Phase 1/2 trial, GlaxoSmithKline is investing in the development of GSK101 (IDE705). However, the financial implications of the IND clearance are more directly relevant to IDEAYA Biosciences.
CONFIDENCE 90
IMPORTANCE 60
RELEVANCE 80